PEER Interactive to Inform the Prescription of Medications

NCT04620499 | Unknown Phase 4 DMC

• 1 other identifier: REB# 2015032
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Improving the prescription accuracy of psychotropic medications for military personnel diagnosed with neuropsychiatric disorders is imperative to promote accelerated treatment response and recovery. This study will determine whether PEER (Psychiatric EEG Evaluation Registry) Interactive (a comparison of a quantitative electroencephalogram (QEEG) to an existing database of subject outcomes) provides an objective adjunctive tool that is more effective in guiding treatment than the current standard of practice in the treatment of military personnel suffering from non-psychotic mental illness. For this prospective, multicenter, randomized, single-blinded, controlled study, 100 participants with a primary diagnosis of a DSM-V depressive disorder, with comorbidity of non-psychotic behavioral disorders to include mild Traumatic Brain Injury (mTBI) and Post Traumatic Stress Disorder (PTSD), will be enrolled. Participants will be randomized into a control or experimental group, and all will undergo a quantitative electroencephalogram (QEEG). For the experimental group, research staff will receive an Outcome Report from PEER Interactive and will follow the guidance of the Report to inform treatment. For the control group, research staff will not receive a participant Outcome Report from PEER Interactive and these participants will be treated based on current standards. For the control group, Outcome Reports will be sequestered for post-hoc analysis. Research staff in collaboration with CNS Response (the Sponsor) will evaluate and validate if the guidance provided by PEER Interactive correlates with the predicted participant outcome. Research staff in collaboration with the Sponsor will also evaluate if the treatment guidance provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in severe adverse events, including suicidality.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16)

  Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) is a 16-item depressive symptomatology self-report questionnaires which has been useful as a way of determining a patient's level of depression before, during, and after treatment. Questions are answered by checking off the most appropriate answer to describe how they have been feeling over the past 7 days and are scored between 0-3 points per question. Total score can range from 0-27 with higher values indicating worse outcomes (5 or lower: no depression, 6 to 10: mild depression, 11 to 15: moderate depression, 16 to 20: severe depression, 21 or higher: very severe depression). The QIDS is score as follows: Sum together the highest score out of Items 1-4, Item 5 score, highest score out of Items 6-9, sum Item 10, 11, 12, 13, and 14, highest score out of Items 15 and 16, sum all of these values for the final total score.

  Change from Baseline to 12 weeks to monitor change in depressive symptomatology.

Study Arms (2)

Experimental

EXPERIMENTAL

EEG-guided drug prescription

Device: EEG

Control

NO INTERVENTION

Will receive EEG, but drugs will be prescribed as usual

Interventions

EEG DEVICE

PEER EEG

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between the ages of 18 - 65 years of age or older who speak and read English.
• Participants able to provide written informed consent to participate in the study.
• Participants with a primary diagnosis of a DSM-V depressive disorder, including subjects with comorbidity of a non-psychotic behavioral disorder.
• Able to stop non-essential medications, including drugs of abuse, for 5 half-lives of the medication(s). See Appendix B for a list of the five half-life time periods for medications.
• The potential subject's primary care physician may be consulted to make these determinations.
• Able to be washed out of non-essential medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix B).
• Participants will be selected from patients on the psychiatric inpatient ward, partially hospitalized patients, and psychiatric outpatients.
• Ability to comply with the requirements of the study.

You may not qualify if:

• Male and female subject less than 18 years old or greater than 65 years old
• Participants who cannot provide written informed consent
• Diagnosis of a psychotic disorder.
• History of, or current, open head brain trauma.
• Subjects with comorbidity of mild traumatic brain injury (mTBI) or traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
• Participants who, in the opinion of the research staff or medical prescriber for non-psychotropic drugs (e.g., primary care, cardiovascular, etc.), would not be good candidates to be washed out of their medications and - in the case of outpatients - are unable to washout medications and/or supplements in a period of 14 days or less.
• Participants currently prescribed Fluoxetine when assessed for study entry (due to long metabolite half-life).
• History of: craniotomy, cerebral metastases, cerebrovascular accident; current diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
• Clinically significant medical illness, including thyroid disorders, which cannot be remediated with medication, e.g. synthroid.
• Known pregnancy and/or lactation, or intent to become pregnant during this study.
• Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
• Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
• Candidates currently stable and considered to be at Maximum Medical Improvement (MMI) on current medications.
• Participant has a positive urine drug screen.
• Participant has active suicidal intent.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (2)

The Royal

Ottawa, Ontario, K1Z 7K4, Canada

Location

University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, K1Z 7K4, Canada

Location

MeSH Terms

Conditions

Depression

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Neuroelectrophysiology and Cognitive Research Laboratory

Model Details: Group A receives treatment as usual (TAU); Group B receives access to the PEER Report (technology under investigation)

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: November 9, 2020
• Study Start: February 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (2)